Gail D. Baura, PhD, is a professor at Keck Graduate Institute in Claremont, CA. She teaches classes in the medical devices and diagnostics track and is one of the nation's foremost experts on system theory applied to patient monitoring. Baura wrote the first textbook combining system theory and patient monitoring, which reviewed cases applying system theory to various detection and measurement algorithms. Baura also has expertise in insulin monitoring and has published several journal articles on that subject. She holds 17 U.S. patents and has another four pending.

Yadin David, PhD,is founder of Biomedical Engineering Consultants LLC (Houston), a firm that provides assessment of medical technology management operations, regulatory compliance, and forensic engineering services for hospitals and industry. For the previous 25 years, David headed the biomedical engineering department and the Center for Telehealth at Texas Children's Hospital (Houston). He holds academic appointments at the Baylor College of Medicine Department of Pediatrics and at the University of Texas, School of Public Health. He is also a visiting professor at the Tec de Monterrey School of Medicine in Mexico. David has been a member of several FDA advisory panels and is a recipient of the FDA commissioner's special citation.

Prakash Gatta, MD,is a practicing and board-certified surgeon with a staff appointment in the division of general surgery at the University of Cincinnati's University Hospital. His clinical focus is esophageal and gastric surgery, with an emphasis on new, minimally invasive approaches to common surgical procedures. He performed the first single-incision laparoscopic cholecystectomy in Cincinnati, and he is the coinventor and provisional patent holder of a tool for single-port laparoscopic access. Gatta is also an assistant professor of surgery at the University of Cincinnati, where he guides undergraduates developing new surgical tools.

Warren Grundfest holds appointments at UCLA as a professor of bioengineering and electrical engineering in the School of Engineering, and as a professor of surgery in the School of Medicine. He also serves as the senior West Coast clinical adviser and portfolio manager for nanomedicine and biomaterials for TATRC (the Telemedicine and Advanced Technology Research Center of the U.S. Army). As one of the nation's foremost experts on medical imaging, Grundfest has received the Stein-Oppenheimer Award for Cancer Imaging. He is also a member of the NASA Space Technology Hall of Fame and a fellow of the American College of Surgeons and SPIE.

Balakrishna Haridas, PhD, is chief technology officer of Biomerix Corp. (Fremont, CA), a medical technology company that develops products for soft tissue repair and reconstruction using its novel biomaterial platform technology. He formerly served as the founder and director of the National Science Foundation Minimally Invasive Medical Technologies Center (MIMTeC), and was the president and founder of Device & Implant Innovations LLC (Mason, OH), a consulting company conducting early- stage R&D projects for U.S. medical device companies.

William Hyman is a professor of biomedical engineering at Texas A&M University. He holds an ScD in engineering mechanics and an MS in engineering mechanics from Columbia University, as well as a BS in mechanical engineering from The Cooper Union. He has served as a consultant for FDA, the National Science Foundation, the National Institutes of Health, the U.S. Army, the General Accounting Office (now known as the Government Accountability Office), medical device companies, and in patent and personal-injury litigation. Among Hyman's honors is a National Defense Education Act fellowship in biomechanics.

Denise M. Korniewicz, PhD, is a professor and senior associate dean for research at the University of Miami School of Nursing and Health Studies, where she also serves as director of the nursing school's research center. Her chief areas of expertise and responsibility include research, grant development, graduate student mentoring, and assisting medical device companies with the development of patient-safety equipment. Her practical nursing experience began in the U.S. Army Nurse Corps, which she left with the rank of captain. She gained experience in the management of critical-care patients as an emergency room charge nurse before undertaking an academic career that has included professorships at the University of Maryland Schools of Nursing and Medicine, Georgetown University Schools of Nursing and Medicine, and Johns Hopkins School of Nursing.

Richard Meyst is president and CEO of Fallbrook Engineering Inc. (Escondido, CA), a contract product development, management, and engineering services consulting firm specializing in healthcare products. He is also principal investigator on an NIH SBIR grant developing a device for the improved collection of cord blood stem cells. Meyst is an accomplished mechanical engineer and developer of a wide range of products for the healthcare and consumer products industries. He has more than 30 years of experience in roles ranging from R&D researcher to program manager. He is recognized as an expert in project management, product conception, design and development, product prototyping, design and process validation, production start-up, cost reduction, and manufacturing engineering.

Mary Beth Privitera is director of the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati. The program focuses on translating research efforts into viable product development opportunities. To date, the program has demonstrated results for clinical specialists in vascular surgery, interventional radiology, general surgery, cardiothoracic surgery, emergency medicine, pulmonary care, rehabilitative medicine, and neurology. She is also an assistant professor of biomedical engineering and an adjunct instructor of industrial design with a research focus in the ergonomics of catheter-based interventions. She is also a principal of Privitera Design (Cincinnati), an international design firm. Privitera has coauthored various sections of the AAMI HE75 and holds several patents and provisional patents.

Molly Follette Story, PhD, is president of Human Spectrum Design LLC. She is an expert in product design and in accessibility and usability of medical instrumentation. She was coeditor of Medical Instrumentation: Accessibility and Usability Considerations (CRC Press, 2007). She was granted six utility patents and has served as a consultant to several companies. She is a member of AAMI's Human Factors Engineering Committee, which is developing the forthcoming AAMI HE75 standard, “Human Factors Design Guidelines for Medical Devices.”

Mark Vreeke, PhD, is senior partner at Rational Systems LLC (Houston), a business process and technical consulting firm. He has been the lead consultant on multiple IVD projects ranging from blood glucose monitors to multianalyte clinical analyzers. He also serves as vice president of R&D
for Rational Biotechnology, a spin-off of Rational Systems. The goal of the spinoff is to speed the adoption of personalized medicine through the development of combined IVD and drug therapy products. In 2007, Vreeke started TransAtlantic Science to commercialize the Lactate EDGE, a sports exercise monitor. The company also specializes in glucose monitoring. Vreeke has 24 U.S. patents.

Stephen Wilcox, PhD, is principal and founder of Design Science (Philadelphia), a 20-person firm that specializes in optimizing the human interface of products—particularly medical products. Wilcox is a member of the Industrial Designers Society of America's (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and, until recently, was chair of the IDSA Human Factors Professional Interest Section. He also served on the human engineering committee of AAMI, which has produced the HE74 Human Factors standard for medical devices and the forthcoming HE75. Wilcox has a PhD in experimental psychology from Penn State, and a certificate in business administration from the Wharton School at the University of Pennsylvania.